- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02812355
Randomized Anticoagulation Trial in Opcab (RATIO) (RATIO)
High Dose Versus Low Dose Heparinization in Patients Undergoing Offpump Coronary Artery Bypass
Study Overview
Detailed Description
Off-pump coronary artery bypass grafting (OPCAB) is an established alternative to on-pump coronary artery bypass grafting (CABG). OPCAB determines a pro-coagulant state potentially deleterious on grafts patency, that is not counterbalanced by the adverse effects of cardiopulmonary bypass on coagulation occurring in CABG, and that lasts as long as one month. Therefore in OPCAB systemic heparinization is necessary to prevent thrombotic complications during transitory occlusion of coronary arteries and grafts. An internationally accepted standard intra-operative anticoagulation protocol for OPCAB has not yet been defined, and heparinization in OPCAB is a highly variable practice. The intraoperative anticoagulation regimen adopted in patients undergoing OPCAB may influence major postoperative outcomes, such as bleeding, transfusion requirements, inflammatory response, myocardial ischemia and grafts patency, but it has never been the object of large-scale randomized controlled trial (RCT). The 2 most widespread intraoperative anticoagulation protocols in OPCAB are represented by full (300 U/kg) or half (150 U/kg) heparinization, with target ACT ranging from 200 sec to >480 sec.
Patients enrolled in the study will be randomized to receive full or half heparinization in a 1:1 ratio using a randomization schedule blocked by site. Randomization will take place in the operatory room by the anesthesiologist, and will be blinded to the surgeon.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Michele NR Triggiani, MD, PhD
- Phone Number: +39-0341253066
- Email: m.triggiani@asst-lecco.it
Study Contact Backup
- Name: Antonello S Martino, MD
- Phone Number: +39-0341253651
- Email: as.martino@asst-lecco.it
Study Locations
-
-
Jilin
-
Changchun, Jilin, China
- Recruiting
- Jilin Heart Hospital
-
Contact:
- Massimo Lemma, MD
- Email: dr.lemma@jlheart.org
-
Principal Investigator:
- Massimo Lemma, MD
-
-
-
-
-
Lecco, Italy, 23900
- Recruiting
- ASST Lecco
-
Contact:
- Michele Triggiani, MD, PhD
- Phone Number: +390341253066
- Email: m.triggiani@asst-lecco.it
-
Sassari, Italy
- Recruiting
- Azienda Ospedaliera Universitaria di Sassari
-
Contact:
- Francesco Massi, MD
- Email: fmassi@aslsassari.it
-
Principal Investigator:
- Michele Portoghese, MD
-
Sub-Investigator:
- Francesco Massi, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Consecutive patients electively undergoing multivessel OPCAB
Exclusion Criteria:
Acute coronary syndrome, on-going double anti-platelets treatment (the second antiplatelet drug should be suspended 5 days before surgery), on-going intravenous heparin or sub-cutaneous low molecular weight heparin, known coagulopathy, documented liver disease, chronic renal failure (creatinine ≥ 2 mg/dl) or previous renal transplantation surgery, previous cardiac surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: half heparinization
heparin I.V. 150 U/kg
|
|
Active Comparator: full heparinization (300 U/kg)
heparin I.V. 300 U/kg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite vascular
Time Frame: 30 days post-operatively
|
Death from vascular causes, perioperative myocardial infarction, stroke.
|
30 days post-operatively
|
Composite major bleeding
Time Frame: 48 hours post-operatively
|
Redo for excessive bleeding, cardiac tamponade, transfusion ≥3 Units of packed red cells or of platelets.
|
48 hours post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative bleeding
Time Frame: 48 hours post-operatively
|
Total bleeding evaluated the morning after surgery (ml.)
|
48 hours post-operatively
|
Transfusion of packed red cells (<3 Units) or of platelets
Time Frame: 30 days post-operatively
|
30 days post-operatively
|
|
Peak value of cardiac biomarker
Time Frame: 30 days post-operatively
|
30 days post-operatively
|
|
Transient ischemic cerebral attack
Time Frame: 30 days post-operatively
|
30 days post-operatively
|
|
Mesenteric ischemia (angiography or CT scan)
Time Frame: 30 days post-operatively
|
30 days post-operatively
|
|
Pulmonary embolus (angiography or CT scan)
Time Frame: 30 days post-operatively
|
30 days post-operatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michele NR Triggiani, MD, PhD, ASST Lecco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EudraCT n. 2016-001529-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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